Cost effective and reliable cell based ELISA as an alternative method of flow cytometry for assessment of binding activity of Vedolizumab.
Cell based ELISA
Flow cytometry
Potency
Vedolizumab
Journal
Heliyon
ISSN: 2405-8440
Titre abrégé: Heliyon
Pays: England
ID NLM: 101672560
Informations de publication
Date de publication:
Feb 2023
Feb 2023
Historique:
received:
02
08
2022
revised:
30
01
2023
accepted:
02
02
2023
entrez:
3
3
2023
pubmed:
4
3
2023
medline:
4
3
2023
Statut:
epublish
Résumé
Vedolizumab is a humanized monoclonal antibody used for inflammatory bowel disease treatment. Vedolizumab binds to the α4β7 integrin complex and inhibits its binding to mucosal addressin cell adhesion molecule-1 (MAdCAM-1). To evaluate the binding efficacy and quality control check of Vedolizumab, flow cytometry is performed by using HuT78 cells. As we know, flow cytometer is costly and require high equipment maintenance with a designated technical manpower to handle it. In this regard, the aim of study was to develop and validate an economical, simple and efficient cell based ELISA assay for potency estimation of Vedolizumab which has not been reported in any pharmacopoeia. The proposed bioassay method was optimized by investigating Vedolizumab binding to α4β7 integrin which is expressed by HuT78 cells. The validation of this method was done at different parameters including specificity, linearity, range, repeatability, precision, and accuracy. The Vedolizumab binding by ELISA results were found specific for Vedolizumab with linearity (R
Identifiants
pubmed: 36865445
doi: 10.1016/j.heliyon.2023.e13570
pii: S2405-8440(23)00777-6
pmc: PMC9970907
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e13570Informations de copyright
© 2023 The Authors. Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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